Why are payers, providers missing the opportunity to make this low-cost testing technology available?

CEO SUMMARY: Since 2014, a toxicology lab at the University of Colorado has used mass spectrometry to offer low-cost, accurate multi-analyte test panels that can detect hundreds of therapeutic drugs and drugs of abuse. However, CU Toxicology’s chief medical officer says health insurers are slow to accept this diagnostic technology, despite its demonstrated clinical benefit and relatively low testing costs. Meanwhile, high schoolers’ ‘fish bowl’ pill parties are a new diagnostic problem.

IT’S A DIAGNOSTICS TECHNOLOGY that is ideal for value-based care. Mass spectrometry is a relatively low-cost system that can detect minute traces of illicit and legitimate drugs in patients. Yet, adoption has been slow among health insurers.

So, what’s the problem? That’s a question Jeffrey Galinkin, MD, is trying to answer. He is a professor of anesthesiology and pediatrics at the University of Colorado School of Medicine. Formerly Galinkin was chief medical officer for CU Toxicology, a lab at Colorado Children’s Hospital that runs mass spectrometry analyzers. He is currently medical director for Claro Scientific Laboratories in Aurora, Colo.

Three years ago, Galinkin developed a multi-analyte test panel that can identify trace amounts of 130 chemicals and hundreds of brand-name and illegal drugs at once and therefore has a wide variety of uses. This testing costs $100 to $200.

In Colorado, the CU Toxicology lab runs mass spec tests to identify drugs in unconscious patients who have overdosed. To manage polypharmacy in elderly patients, mass spec tests can identify prescription drugs that older Americans may be unaware they’ve taken. And mass spec is used for patients in drug clinics to demonstrate that they are clean and sober—or not. Physicians managing patients in pain also use this technology.

There are a wide variety of uses for mass spectrometry in clinical diagnostics. A few years ago, a long-term care facility in Colorado used the mass spec toxicology panels from CU Toxicology to find one resident was dealing cocaine. Kaiser Permanente Colorado also refers these tests to Galinkin’s lab. (See TDR, Feb. 24, 2014.)

Billing Issue Slows Adoption

“Despite the high sensitivity and low cost, mass spec-based assays are not widely recognized for what they could do for the U.S. healthcare system,” noted Galinkin. “It’s a technology that is slow to be adopted because of the billing implications. We are having discussions about spinning off this technology. But for now, we can’t bill for these tests efficiently because health insurers have been slow to understand this technology.

“At Colorado Children’s Hospital, billing for our physician group is done through the University Physicians group,” he explained. “The billing for our lab test is too complex because normally physicians don’t bill for lab tests. That’s why we’re considering different ways to run this operation.”

While billing is one problem, there’s also not much interest in this relatively new diagnostic technology for another reason. “Many labs prefer to do more traditional toxicology testing that generates more income,” offered Galinkin.

“We compete against billion-dollar lab companies that are set up to charge $1,200 to $1,400 a sample,” he commented. “For many reasons, their methods generate more revenue.

Lab Staff In Doctor’s Offices

“Then there are the situations where certain lab companies that do toxicology and pain management testing have people implanted in doctors’ offices to help collect patients’ samples and send them to certain labs,” noted Galinkin. “Those companies don’t want to change their ways.”

Another hurdle involves testing for therapeutic drugs and drugs of abuse in patients seeking to cheat on their drug tests. “Most labs offering this type of testing prefer to have patients use the pee-cup method for specimen collection because they don’t understand the deficiencies of common technologies used in such testing,” said Galinkin. “They don’t realize that many patients know how to get around that testing.

“For example, a patient can drink a liter of cranberry juice just before the test,” he explained. “Then acidity in the juice screws up the result.

“Some people will just drink a gallon or more of water to mess with pee-cup samples,” explained Galinkin. “Addicts know how to substitute someone else’s urine. There is also an entire industry that sells urine substitutes designed specifically to help patients cheat on their drug tests.

“But our mass spec-based testing can identify when patients try to fool the system,” he declared. “We can detect when a sample is too acidic and when a sample was tampered with because we can show the molecular signature of the patient and the sample. Mass spec resists this type of sample-tampering.

Advantages Not Recognized

“Yet, health insurers have not yet recognized that mass spec has these advantages, along with lower costs compared to existing test methodologies,” Galinkin said.

In Colorado, Kaiser Permanente has contracted with CU Toxicology, but that’s just one health plan, he added. In an interview for THE DARK REPORT in 2014, Galinkin explained that the mass spec test panel they designed detects 112 chemicals.

Mass spectrometry technology has improved since then. “CU Toxicology has upgraded its machines from the AB Sciex 5500 to the AB Sciex 6500,” noted Galinkin. “Now, the molecules are easier to detect because the machines are more sensitive, which makes the testing even easier.

“The CU Toxicology lab still does tox testing for University Hospital, Colorado Children’s Hospital, some work for Kaiser, and for the adolescent abuse centers around the city,” Galinkin explained. “Most of those tests are done on a fee-for-service basis. For some tests, the hospital will pay us a fee and then bill an insurer. That turns out to be a much more manageable solution than for our physician group to bill insurance companies directly.

Significant Investment

“For us to bill an insurer would require making a significant investment with a company that specializes in billing insurance companies and understands the coding and claims processes for clinical laboratory tests,” he explained. “That would be one way to move forward, but it’s costly for us.”

Meanwhile, a technology that would be ideal for clinical labs to use to deliver value-based care is not reaching its full potential, he said. “To me, it’s shocking that health insurers have yet to recognize what this technology can do,” observed Galinkin. “As a diagnostic tool, mass spec is too much of a money-saving technology to go unnoticed for too long. At some point health plans will realize the value. It’s just not there yet.”

Experts predict that mass spectrometry will play ever-greater roles in both clinical laboratories and anatomic pathology labs because of the substantial and ongoing technology advances in this field. Developing areas in this field include tandem mass spectrometry (MS/MS) combined with separation technologies such as gas chromatography (GC), liquid chromatography (LC), and ion mobility spectrometry (IMS). These allow ever smaller concentrations and metabolites to be targeted. An emerging approach to study proteins uses macromolecule ionization methods, such as electrospray ionization (ESI) and matrix-assisted laser desorption/ionization (MALDI).